MAUDE Adverse Event Report: ST PAUL CADD; SET, ADMINISTRATION, INTRAVASCULAR

Model Number 21-7302-24

Device Problems Fluid/Blood Leak (1250); Leak/Splash (1354)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/03/2020

Event Type  malfunction  

Event Description

Information was received indicating that when filling the smiths medical cadd cassette reservoir, the bag has been breaking in the cassette, leaking the medication.It was reported that a syringe attached at the end was used to add drug and it started to leak out of the cassette.No patient consequences were reported.No adverse effects were reported.

Manufacturer Narrative

Other, other text: once cassette was returned.Leak testing was performed and the unit was found to be leaking on the joint of the tube.The bag sealer machine id# bfm-2-1-001 was causing the weak seal condition on the joint of the tube with the bag, the generator of the equipment was identified.Procedure not followed: the two forms related to the procedures pm-1011 and pm-1026, for to register units with leak were not filling up, even that was identified the equipment malfunction, as well the method to test the units in both process was not followed as is required, forcing the equipment to release parts with potential leak condition.No corrective actions have been identified at this time; our investigation remains in progress.

• Brand Name: CADD
• Type of Device: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): ST PAUL; 1265 grey fox rd.; st. paul MN 55112
• MDR Report Key: 11100317
• MDR Text Key: 224528146
• Report Number: 3012307300-2020-12915
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 10610586027239
• UDI-Public: 10610586027239
• Combination Product (y/n): N
• PMA/PMN Number: K040636
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup
• Report Date: 04/26/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/31/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 21-7302-24
• Device Catalogue Number: 21-7302-24
• Device Lot Number: 4046848
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/08/2021
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/30/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1